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TracPatch Wearable Device for Knee Replacement Surgery Recovery

N/A
Waitlist Available
Led By Victor Hernandez
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Surgical candidate for total knee arthroplasty
Greater than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks after surgery
Awards & highlights

Study Summary

This trial is testing a new wearable device that could improve patient outcomes after surgery by allowing patients and surgeons to monitor recovery in real time.

Who is the study for?
This trial is for adults over 18 who are about to have knee replacement surgery due to osteoarthritis and can consent. They must be able to use a smartphone with Bluetooth. It's not for those who've had the same surgery on that knee, have severe knee deformities, or complex cases as judged by their surgeon.Check my eligibility
What is being tested?
The study tests the Consensus TracPatch, a wearable device tracking recovery after knee surgery using motion and temperature sensors. It aims to improve post-op mobility and patient-doctor communication by providing real-time data.See study design
What are the potential side effects?
Since this trial involves a non-invasive monitoring device, there are no direct side effects like you'd expect from medication. However, skin irritation or an allergic reaction to the wearable's materials could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for a total knee replacement surgery.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Range of Motion
Secondary outcome measures
Knee
Patient-Reported Outcome Measurement Information System (PROMIS)
Visual Analogue Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Wearable Technology GroupExperimental Treatment1 Intervention
Patients in this arm will be provided with their own Consensus TracPatch wearable device postoperatively and instructed on its use for six weeks.
Group II: Current Standard of Care GroupActive Control1 Intervention
Patients in this arm will not be provided with any wearable device. Participants will be evaluated as part of the study for a total of six weeks.

Find a Location

Who is running the clinical trial?

Consensus OrthopedicsUNKNOWN
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,501 Total Patients Enrolled
1 Trials studying Osteoarthritis
84 Patients Enrolled for Osteoarthritis
Victor HernandezPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
University of Miami Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
BMJ OpenJournal
Impact of Wearable Technology on Psychosocial Factors of Osteoarthritis Management: A Qualitative Study
Belsi, Athina, Enrica Papi, and Alison H McGregor. 2016. “Impact of Wearable Technology on Psychosocial Factors of Osteoarthritis Management: A Qualitative Study”. BMJ Open. BMJ. doi:10.1136/bmjopen-2015-010064.
International Journal of SurgeryJournal
A Wearable Mobility Assessment Device for Total Knee Replacement: A Longitudinal Feasibility Study
Kwasnicki, Richard M., Raza Ali, Stevan J. Jordan, Louis Atallah, Julian J.H. Leong, Gareth G. Jones, Justin Cobb, Guang Zhong Yang, and Ara Darzi. 2015. “A Wearable Mobility Assessment Device for Total Knee Replacement: A Longitudinal Feasibility Study”. International Journal of Surgery. Elsevier BV. doi:10.1016/j.ijsu.2015.04.032.
Knee Surgery, Sports Traumatology, ArthroscopyJournal
Functional Improvement After Unicompartmental Knee Replacement: A Follow-up Study with a Performance Based Knee Test
Kleijn, Lucas L. A., Wouter L. W. van Hemert, Will G. H. Meijers, Arnold D. M. Kester, Lukas Lisowski, Bernd Grimm, and Ide C. Heyligers. 2007. “Functional Improvement After Unicompartmental Knee Replacement: A Follow-up Study with a Performance Based Knee Test”. Knee Surgery, Sports Traumatology, Arthroscopy. Springer Science and Business Media LLC. doi:10.1007/s00167-007-0351-7.
Journal of Medical Engineering & TechnologyJournal
Assessing Post-anterior Cruciate Ligament Reconstruction Ambulation Using Wireless Wearable Integrated Sensors
Arosha Senanayake, S. M. N., Owais Ahmed Malik, Pg. Mohammad Iskandar, and Dansih Zaheer. 2013. “Assessing Post-anterior Cruciate Ligament Reconstruction Ambulation Using Wireless Wearable Integrated Sensors”. Journal of Medical Engineering & Technology. Informa UK Limited. doi:10.3109/03091902.2013.837529.
All > Osteoarthritis Knee
~2 spots leftby Jun 2024
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